# K974434: Osteonics Series 7000 Total Knee Anterior Femoral Blocks

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Jan 12, 1998 after 49 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Osteonics® Series 7000 Distal Femoral Bone Augmentation Block and Posterior Femoral Bone Augmentation Block: named in the summary without a submission number

## Indications for use
The Osteonics® Anterior Femoral Blocks, because they are accessory components to an existing total knee replacement system, are subject to the general indications and contraindications of their mating knee femoral components, as follows: General Indications for Total Knee Replacement Components Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis. Post-traumatic loss of knee joint configuration and function. Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. Revision of previous unsuccessful knee replacement or other procedure. Indications Specific to the Femoral Wedges Painful, disabling joint disease of the knee secondary to degenerative arthritis, theumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss. Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss. Polymethyl methacrylate (PMMA) bone cement will be used to affix a selected femoral block to its mating knee femoral component. The assembled block-to-femoral component construct is intended for cemented fixation to the prepared distal femur.

Source page: https://510kreport.com/device/K974434
Methodology: https://510kreport.com/methodology